FDA device listing
Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation,Single Use Plasma Coagulation Probe…
FDA device listing 1897906534 · ATL Technology LLC
Key facts
| Proprietary names | Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation,Single Use Plasma Coagulation Probe Axial Argon PA-210K, 1.5 x 1500 mm,Single Use Plasma Coagulation Probe Axial Argon PA-210Z, 1.5 x 3000 mm,Single Use Plasma Coagulation Probe Axial Argon PA-211U, 2.3 x 2200 mm,Single Use Plasma Coagulation Probe Axial Argon PA-211Z, 2.3 x 3000 mm,Single Use Plasma Coagulation… |
|---|---|
| Owner/operator | ATL Technology LLC |
| Owner/operator number | 10045899 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | GYRUS MEDICAL LTD. |
| Establishment registrations | 9617070 |
| FEI numbers | 3002807134 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database